Endogenous Opioid Modulation by Ketamine

Phase 3

Withdrawn

• Conditions: Major Depressive Disorder
• Interventions: Drug: Ketamine Hydrochloride; Other: Normal saline

• Registration Number: NCT03051945
• Lead Sponsor: University of Utah

Brief Summary

Demonstrate the acute effects of ketamine on endogenous µ-opioid neurotransmission in humans.

Detailed Description

This study will test the hypothesis that the rapidly-acting antidepressant ketamine improves core depressive symptoms by acutely activating the brain's endogenous µ-opioid system.

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Study Start: 2019-08
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18-65
• DSM-5 major depressive disorder
• Current moderate-to-severe, treatment-resistant, depressive episode
• Patient Health Questionnaire (PHQ-9) total score ≥ 10
• PHQ-9 item score ≥ 2 on "Little interest or pleasure" item
• PHQ-9 item score ≥ 2 on "Feeling down, depressed, or hopeless" item
• Medical documentation of depression for at least 2 months
• Inadequate response to at least one adequate antidepressant medication trial in the current episode

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Exclusion Criteria

• Current episode duration >5 years
• Moderate-to-severe DSM-5 substance use disorder (past year)
• Cognitive disorder (past year)
• Post-traumatic stress disorder (past year)
• Obsessive compulsive disorder (past year)
• Personality disorder (past year)
• Positive urine drug screen
• Psychotic symptoms
• Mania
• Significant neurologic disorder or injury
• Breastfeeding or pregnancy
• Imminent suicide risk
• Current use of CYP3A4 inhibitors (e.g., ketoconazole or erythromycin)
• Other unstable psychiatric or medical condition requiring a higher level of care
• Contraindication to ketamine, MRI, or PET

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine Hydrochloride	Ketamine will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).
Placebo	Normal saline	Normal saline will be infused via intravenous catheter over 40 minutes (0.75 mg/kg/hr over 40 minutes, 0.5 mg/kg total).

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale at 24 hours, change from baseline	24 hr	total score on the 17-item Hamilton Depression Rating Scale

Trial Locations

Locations (1)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States